Safety evaluation of PRP-D haemophilus influenzae type b conjugate vaccine in children immunized at 18 months of age and older: Follow-up study of 30000 children

Constance M. Vadheim, David P. Greenberg, S. Michael Marcy, Joel I. Ward, James Froeschle

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

We evaluated the safety of the PRP-D conjugate Hib vaccine (ProHIBit®, Connaught) in 29 309 children vaccinated at 18-60 months of age in the Southern California Kaiser Permanente medical clinics during the period April 1, 1988, to July 31, 1989. Surveillance for potential reactions involved postcard questionnaires, telephone surveys, reports of Kaiser staff and review of hospitalizations and covered two periodsfollowing immunization: (1) the first 48 hours and (2) days 2 through 30. Surveillancefor invasive Hib disease involved the above methods in addition to systematic reviewsof laboratory and hospital records through January 31, 1990. Rates of local and systemic reactions within 48 hours of vaccination with PRP-D alone were low (≤2%for fever >102$F, local redness or swelling) and similar to those previouslyreportedafter vaccination with PRP. Hospitalization and seizures (0.15% and 0.09% of vaccinated children, respectively) occurring within 1 month of immunization appeared to be unrelated to vaccination. One 29-month-old child had onset of a fatalepisode of Hib sepsis/meningitis within 48 hours of vaccination. Also, a 30-month-oldchild developed Hib meningitis 10 months after PRP-D vaccination.

Original languageEnglish
Pages (from-to)555-561
Number of pages7
JournalPediatric Infectious Disease Journal
Volume9
Issue number8
DOIs
StatePublished - 1 Jan 1990
Externally publishedYes

Keywords

  • Haemophilus influenzae type B
  • PRP-conjugate vac-cine
  • vaccine adverse reactions

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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